In short
This article provides detailed information about 2 ongoing clinical trials investigating new treatments for B-cell unclassifiable lymphoma high grade. These trials are testing different medication combinations and treatment approaches to improve outcomes for patients with this aggressive type of lymphoma.
Clinical trial locations
- Germany
- Greece
- Poland
Study on Acalabrutinib with Rituximab and Drug Combination for Older Adults with Untreated Diffuse Large B-Cell Lymphoma
This clinical trial is designed for older adults who have not yet received treatment for diffuse large B-cell lymphoma, an aggressive type of blood cancer. The study is being conducted in Germany and Greece.
Who can participate: The trial is open to patients over 80 years old, or those between 60 and 80 years who are not healthy enough for full-dose chemotherapy. Participants must have a confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma or related types, with disease staged according to the Ann Arbor Classification. Their general health status should allow them to perform daily activities, though some limitations due to the disease are acceptable. Important laboratory requirements include adequate blood cell counts, liver function, and kidney function, unless these are affected by the lymphoma itself. Both men and women must agree to use highly effective contraception during the study.
Who cannot participate: The study excludes patients who have already received treatment for this type of lymphoma, those younger than 60 who are fit enough for full-dose chemotherapy, and anyone with severe heart problems or uncontrolled medical conditions. Patients with active infections requiring treatment, pregnant or breastfeeding women, and those participating in other clinical trials at the same time are also excluded. Additionally, individuals with allergies to the study medications or other serious diseases that might interfere with the research cannot join.
What the trial involves: The main goal is to determine whether adding acalabrutinib to a reduced chemotherapy regimen called R-miniCHOP can help patients live longer without their disease worsening. Acalabrutinib works by blocking a protein that helps cancer cells grow. The R-miniCHOP regimen includes rituximab (which helps the immune system destroy cancer cells), along with chemotherapy drugs doxorubicin, cyclophosphamide, vincristine sulfate, and prednisone or prednisolone. Participants will be randomly assigned to receive either the combination treatment with acalabrutinib or the standard R-miniCHOP alone, with some possibly receiving a placebo for comparison. Throughout the trial, patients will undergo regular check-ups, blood tests, and imaging studies to monitor their health and disease progression, followed by long-term follow-up visits after treatment completion.
Study on the Effectiveness and Safety of Cytarabine, Tafasitamab, and Lenalidomide for Patients with Relapsed Diffuse Large B-Cell Lymphoma
This clinical trial focuses on patients whose diffuse large B-cell lymphoma or high-grade B-cell lymphoma has come back after initial treatment. The study is taking place in Poland and is expected to continue until early 2026.
Who can participate: Eligible patients must be at least 18 years old with a confirmed diagnosis of diffuse large B-cell lymphoma or high-grade B-cell lymphoma. They must have already been treated with standard chemotherapy regimens like R-CHOP, R-CHOP-like, Pola-R-CHP, or DA-EPOCH-R, and achieved complete remission confirmed by a PET-CT scan after completing first-line treatment. Participants need to have specific test results available, including mutation analysis from blood samples taken before their first treatment and assessments of circulating tumor DNA during and after treatment. Their general health status should allow them to carry out normal activities or have only minor restrictions. Women of childbearing age must have a negative pregnancy test and agree to use effective contraception. All participants must be willing to provide tissue samples from their original diagnosis if needed and commit to using contraception during the trial and for a specified period afterward.
Who cannot participate: The study excludes patients with other types of cancer unrelated to diffuse large B-cell or high-grade B-cell lymphomas. Those who have not fully recovered from previous cancer treatments or their side effects cannot join. Individuals with severe heart problems, uncontrolled high blood pressure, or active infections requiring treatment are not eligible. Pregnant or breastfeeding women are excluded, as are patients with a history of allergic reactions to similar treatments. Anyone with serious medical conditions that could interfere with the study or who cannot follow study procedures and attend required visits is also excluded.
What the trial involves: The study uses an innovative approach by monitoring levels of tumor DNA in the blood to guide treatment decisions. This method helps doctors detect if the cancer is returning early, allowing them to start a second round of treatment sooner. The investigational approach involves several medications: cytarabine, tafasitamab (also known as MOR00208), and lenalidomide, along with dexamethasone, cisplatin, bendamustine hydrochloride, polatuzumab vedotin, and rituximab. These medications are given in various forms including oral tablets and intravenous infusions. The main goal is to evaluate the overall response rate to this DNA-guided early intervention and monitor any significant side effects. Throughout the trial, participants will undergo regular blood tests to measure circulating tumor DNA, imaging tests like PET-CT scans, and quality of life assessments using a specific questionnaire. This approach aims to catch cancer recurrence early and potentially improve treatment outcomes.
Summary
Currently, there are 2 ongoing clinical trials for B-cell unclassifiable lymphoma high grade, representing different treatment approaches for this aggressive disease. These trials are being conducted across three European countries: Germany, Greece, and Poland.
The trials address two distinct patient populations and disease stages. The first study focuses on older adults who have not yet received treatment, testing whether adding acalabrutinib to a reduced-intensity chemotherapy regimen can improve outcomes for patients who are not fit enough for standard full-dose treatment. The second trial targets patients whose disease has returned after initial therapy, using an innovative approach that monitors tumor DNA in the blood to guide early intervention with a combination of multiple medications.
Both trials reflect ongoing efforts to develop more effective and personalized treatment strategies for this challenging condition. The DNA-guided approach in the Polish study represents a particularly novel strategy for detecting disease recurrence early and starting treatment promptly. Patients interested in participating should discuss these options with their healthcare team to determine which trial, if any, might be appropriate for their specific situation.
